Effect of a Simplified Mindfulness Intervention on Health-related Quality of Life in Patients Undergoing Hematopoietic Stem Cell Transplantation: A Prospective Single-Center Randomized Controlled Trial

Not Applicable

Not yet recruiting

• Conditions: Hematopoietic Stem Cell Transplantation

• Registration Number: NCT07127562
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Brief Summary

This study aims to evaluate the impact of a simplified mindfulness intervention (daily mindfulness breathing and body scanning) during hospitalization in the transplant ward on health-related quality of life in hematopoietic stem cell transplantation patients.

Detailed Description

All patients undergo standardized HSCT treatment, which does not interfere with the management of their underlying conditions. Patients are randomly assigned to either the 'Mindfulness Intervention Group' or the 'Conventional Support Group' based on age (whether over 40) and transplant type (autologous or allogeneic), in a 1:1 ratio. The study period is at least 21 days, during which patients are hospitalized in the transplant ward.

Study Timeline

• Status Verified: 2025-07
• Study Start: 2025-08-07
• Study First Submitted: 2025-08-11
• Study First Submitted QC: 2025-08-11
• Last Update Submitted: 2025-08-11
• Study First Posted: 2025-08-17
• Last Update Posted: 2025-08-17
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

1. Aged 18 years or older.
2. Scheduled to receive either autologous or allogeneic HSCT.
3. Anticipated inpatient stay in the transplant unit of at least 21 days.

Exclusion Criteria

1. Prior history of hematopoietic stem cell transplantation (HSCT).
2. Active psychiatric disorder or cognitive impairment.
3. Systematic training in mindfulness/mindfulness-based interventions/yoga within the past 3 months.
4. Contraindications to MRI.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in FACT-BMT Score (Δ Score)	baseline to Day 28	The daily trajectory of FACT-BMT total scores during hospitalization will be continuously monitored in both the mindfulness intervention group and the routine support group. The difference between the lowest daily score and the baseline score (Δ nadir) will be calculated to reflect the maximum decline in quality of life during hospitalization. A comparison will be made between the two groups to determine whether there is a difference in the maximum reduction of FACT-BMT total scores during hospitalization, thereby evaluating the mitigating effect of mindfulness intervention on the deterioration of quality of life.

Secondary Outcome Measures

Name	Time	Method
Change in HADS score	Baseline, Day 28	Assessing trends in emotional improvement.
MoCA cognitive function	baseline ，Day 28	Evaluating cognitive performance.
Subjective Well-Being Scale (SWB)	baseline, Day 28	Measuring life satisfaction and quantifying emotional experiences
Pittsburgh Sleep Quality Index (PSQI)	baseline, Day 28	Quantifying sleep quality
EQ-5D-5L score	baseline ，Day 28	Includes 5-dimensional scores and Visual Analog Scale (VAS) ratings to reflect subjective health status
Incidence of bloodstream bacterial infections in the transplant unit	From Day 0 through discharge	Including the number of positive bacterial blood cultures
Post-Traumatic Growth Inventory (PTGI)	baseline, Day 28	Assessing the degree of personal growth following traumatic experiences
MRI structural changes	Day 0, Day 28	Hippocampal volume, dorsolateral prefrontal cortex (DLPFC) thickness, and surface area